Cleared Traditional

K955802 - PATHFINDER

K955802 is an FDA 510(k) clearance for PATHFINDER, manufactured by Cardima, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 404-day FDA review.

K955802 · Cardima, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
404d
Days
Class 2
Risk

K955802 is an FDA 510(k) clearance for the PATHFINDER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Cardima, Inc. (Fremont, US). The FDA issued a Cleared decision on January 29, 1997 after a review of 404 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cardima, Inc. devices

FDA 510(k) Submission Details - K955802

510(k) Number K955802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date January 29, 1997
Days to Decision 404 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 125d · This submission: 404d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 112
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K955802.
PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
K970853 · Cardima, Inc. · Nov 1997
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · C.R. Bard, Inc. · Oct 1997
ARRHYTHMIA MAPPING SYSTEM (8100/8300)
K965066 · Cardiac Pathways Corp. · Aug 1997
ELECTRODE RECORDING CATHETER
K954651 · Boston Scientific Corp · Oct 1996
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · Boston Scientific Corp · Mar 1996
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
K953651 · Arrow Intl., Inc. · Nov 1995